A Trial in Healthy Participants to Evaluate the Pharmacokinetics, Safety, Tolerability and Food Effects of PRAX-562

Phase 1

Completed

• Conditions: Epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12620001292965
• Lead Sponsor: Praxis Precision Medicines

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-30
• Study Completion: 2021-07-28
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Female or male and between the ages of 18 and 55 years, inclusive.
- Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2 (inclusive).
- Medically healthy (without significant medical issues, e.g. high blood pressure)

Exclusion Criteria

- Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug.
- Any abnormal ECG findings, laboratory value or physical examination findings
- Positive ethanol, drug screen or cotinine test
- Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 2 weeks
- Use of any experimental or investigational drug or device within 30 days
- Donation or loss of 400 mL or more of blood within 8 weeks and/or donation of plasma within 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified